AB1330 FREQUENCY OF DISEASE FLARE AND ITS RISK FACTORS FOLLOWING TWO-DOSE OF COVID-19 VACCINATION IN PATIENTS WITH RHEUMATOID ARTHRITIS
Authors: S. Kojima, Y. Kondo, Y. Sakai, S. Kasai, J. Kikuchi, Y. Kaneko
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Amid the coronavirus disease 2019 (COVID-19) crisis, two messenger RNA (mRNA) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have benefitted most people worldwide. However, the safety of vaccine has not been established in patients with rheumatic arthritis (RA). Previous studies reported that flares of underlying RA following SARS–CoV-2 vaccination were not so frequent, and there was no report of severe flare. However, those reports did not assess patients' disease activity with validated disease activity measures and described only simple self-reported questionnaires. Hence, the effect of vaccination on disease activity in patients with RA is still unclear. Understanding the association between arthritis flare in patients in RA and vaccination is important to overcome vaccine hesitancy. <h3>Objectives</h3> To clarify the effect of SARS-CoV-2 vaccination on disease activity in patients with RA and identify risk factors associated with RA flares following the vaccination. <h3>Methods</h3> This is a prospective cohort study in patients with rheumatic musculoskeletal disease including RA who received the SARS-CoV-2 mRNA vaccines BNT162b2 or mRNA-1273 from March 16, 2021, at Keio University Hospital. The disease activity was evaluated with disease activity score for 28 joints using C-reactive protein (DAS28), simplified disease activity index (SDAI), and clinical disease activity index (CDAI) before vaccination and after second vaccination (within two months). RA flare was defined as ΔDAS28-CRP&gt;0.6with requirement of treatment intensification. All analysis in this study was carried out with JMP. <h3>Results</h3> We enrolled 318 patients with RA in this analysis. The mean age was 61 years old, and 283 (89%) were female. The mean DAS28-CRP before vaccination and after 2nd dose of vaccination were 1.70±0.71 and 1.78±0.81, respectively (p=0.84). The increase in DAS28-CPR after vaccination &gt; 0.6 was observed in 53 patients (16.7%), and among them, 23 patients (8.2%) needed treatment intensification. The types of SARS-CoV-2 vaccine, humoral immunogenicity including neutralizing antibody titer and its adverse effects including systemic reaction (fever or general fatigue) were not different between the flare and non-flare groups (9.8 vs 9.1 IU/mL, p=0.88; 31.2% vs 18.7%, p=0.32, respectively). In the flare group, swollen joint counts (SJC), hourly erythrocyte sedimentation rates, DAS28-CRP, and SDAI were significantly higher than those in the non-flare group (0.5 vs 0.0, p&lt;0.000; 13 vs 11 mm/h, p=0.01; 1.57 vs 1.45, p&lt;0.001; 3.9 vs 2.4, p=0.02, respectively). Multivariable logistic regression analysis revealed that the number of swollen joints before vaccination contributed RA exacerbation after SARS-CoV-2 vaccination significantly (odds ratio 1.3, 95% confidence interval 1.06-1.65, p=0.01). The receiver operating curve analysis identified that having two or more swollen joint counts predicts RA flares after vaccination with an area under the curve of 0.64, a sensitivity of 42.3%, and a specificity of 86.9%. <h3>Conclusion</h3> Disease flare with requirement of treatment intensification is observed in 8.2% of patients with RA. Patients with higher disease activity, especially having two or more swollen joint counts are at high risk of flare following mRNA SARS-CoV-2 vaccination. <h3>Reference</h3> [1]Connolly CM, Ruddy JA, Boyarsky BJ, et al. Disease Flare and Reactogenicity in Patients With Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination. Arthritis Rheumatol. 2022;74(1):28-32. doi: 10.1002/art.41924. Epub 2021 Dec 3. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.